GSK plc (LSE/NYSE: GSK) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted SENKU (formerly known as SAKIGAKE) designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB). SENKU designation is granted based on the level of innovation, severity of disease, and prominent efficacy.

葛兰素史克股份有限公司（伦敦证交所/纽约证交所：葛兰素史克）今天宣布，日本厚生劳动省（MHLW）已授予SENKU（以前称为SAKIGAKE）贝匹罗维森的称号，贝匹罗维森是一种用于治疗慢性乙型肝炎（CHB）的研究性反义寡核苷酸（ASO）。SENKU名称是根据创新水平，疾病严重程度和显着疗效授予的。

The goal of SENKU designation is to increase early patient access to innovative medicines through an expedited review process to treat serious conditions and fill an unmet medical need..

SENKU指定的目标是通过加速审查过程来增加患者早期获得创新药物的机会，以治疗严重疾病并满足未满足的医疗需求。。

The designation is based on results from the phase IIb B-Clear and B-Sure trials1,2 which evaluated the efficacy, safety and durability of response of bepirovirsen in people with CHB. A confirmatory phase III programme, B-Well, is ongoing. This is the second regulatory designation in 2024 for bepirovirsen, following the US Food and Drug Administration (FDA) Fast Track designation for bepirovirsen granted earlier this year.

该名称基于IIb期B-Clear和B-Sure试验1,2的结果，该试验评估了贝匹罗韦在CHB患者中的疗效，安全性和持久性。。这是继美国食品和药物管理局（FDA）今年早些时候授予贝比洛韦森快速通道指定之后，贝比洛韦森在2024年获得第二个监管指定。

Further information is available at: https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-fast-track-designation-for-bepirovirsen-in-chronic-hepatitis-b..

有关更多信息，请访问：https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-fast-track-designation-for-bepirovirsen-in-chronic-hepatitis-b..

CHB affects 257 million people worldwide, and nearly 1 million people in Japan.3 Current treatment options provide a functional cure rate of less than 2-8% for pegylated interferon (PegIFN) and less than 1% for oral treatments (nucleoside/nucleotide analogues [NAs]).4 Functional cure occurs when the hepatitis B virus DNA and viral protein, hepatitis B surface antigen (HBsAg), are at levels low enough to be undetectable in the blood and can be controlled by the immune system without medication.

CHB影响全球2.57亿人，日本近100万人[3]。目前的治疗方案对聚乙二醇化干扰素（PegIFN）的功能治愈率低于2-8%，口服治疗（核苷/核苷酸类似物）的功能治愈率低于1%[4]。当乙型肝炎病毒DNA和病毒蛋白，乙型肝炎表面抗原（HBsAg）的水平低到足以在血液中检测不到，并且可以在没有药物的情况下由免疫系统控制时，就会发生功能治愈。

Current therapies only suppress the virus and do not directly lower HBsAg, which is essential for functional cure..

目前的疗法只能抑制病毒，不能直接降低HBsAg，这对于功能性治疗至关重要。。

Bepirovirsen is the only single agent in phase III development that has shown the potential to achieve clinically meaningful functional cure response when combined with oral NAs. Bepirovirsen is also being investigated as a potential backbone therapy in future sequential regimens to pursue functional cure in a broader population of patients with CHB..

Bepiroversen是III期开发中唯一一种单药，与口服NAs联合使用时，有可能实现临床上有意义的功能性治愈反应。Bepiroversen也正在研究作为未来序贯方案中潜在的骨干疗法，以在更广泛的CHB患者群体中寻求功能性治愈。。

About the B-Clear and B-Sure phase IIb trials

关于B-Clear和B-Sure IIb期试验

The B-Clear trial consisted of two parallel cohorts, one for patients receiving NA treatment and the other for patients who were not-on-NA. Further information is available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2210027.

B-Clear试验由两个平行队列组成，一个用于接受NA治疗的患者，另一个用于未接受NA治疗的患者。有关更多信息，请访问：https://www.nejm.org/doi/full/10.1056/NEJMoa2210027.

Longer term efficacy and durability of response is being investigated in the B-Sure trial, which follows participants from the B-Clear study for an additional 33 months and includes criteria for stopping NA therapy to evaluate the potential for functional cure in patients who successfully stop all medication and continue to demonstrate no serologic evidence of hepatitis B surface antigen (HBsAg) or HBV DNA..

B-Sure试验正在研究反应的长期疗效和持久性，该试验对B-Clear研究的参与者进行了另外33个月的跟踪研究，其中包括停止NA治疗的标准，以评估成功停止所有药物治疗并继续证明没有乙型肝炎表面抗原（HBsAg）或HBV DNA血清学证据的患者功能治愈的可能性。。

About B-Well 1 and B-Well 2 phase III trials

关于B井1和B井2的III期试验

These two multi-centre, randomised, double-blind, placebo-controlled phase III trials (B-Well 1 and B-Well 2) assess the efficacy, safety, pharmacokinetic profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression with bepirovirsen treatment in nucleos(t)ide analogue (NA)-treated participants with chronic hepatitis B and baseline HBsAg <=3000 IU/ml.

这两项多中心，随机，双盲，安慰剂对照的III期临床试验（B-Well 1和B-Well 2）评估了贝比洛韦治疗慢性乙型肝炎和基线HBsAg<=3000 IU/ml的受试者的疗效，安全性，药代动力学特征和乙型肝炎病毒表面抗原（HBsAg）抑制的持久性。

The primary endpoint of the trials is the number of participants achieving functional cure with baseline HBsAg ≤3000 IU/mL..

试验的主要终点是基线HBsAg≤3000 IU/mL达到功能性治愈的参与者人数。。

About CHB

关于CHB

Hepatitis B is a viral infection of the liver, caused by the hepatitis B virus, that can cause both acute and chronic liver disease.5 Chronic hepatitis B (CHB) is a long-lasting infection and occurs when the body’s immune system is unable to fight off the virus and it persists in the blood and liver.5 CHB is a major global health issue, affecting 257 million people across the world,3 although only about 13% of these people have a diagnosis and only 3% receive treatment.6 CHB can progress to more serious conditions like cirrhosis and liver cancer, and more than a million people die from this infection every year..

乙型肝炎是由乙型肝炎病毒引起的肝脏病毒感染，可引起急性和慢性肝病。慢性乙型肝炎（CHB）是一种长期感染，当人体免疫系统无法抵抗病毒并持续存在于血液和肝脏中时就会发生。5 CHB是一个重大的全球健康问题，影响着全世界2.57亿人，3尽管这些人中只有约13%被诊断，只有3%接受治疗。6 CHB可以发展为肝硬化和肝癌等更严重的疾病，每年有超过100万人死于这种感染。。

About bepirovirsen (GSK3228836)

关于贝匹罗韦森（GSK3228836）

Bepirovirsen is a triple action investigational antisense oligonucleotide (ASO), currently being evaluated in the B-Well phase III clinical trial programme for the treatment of CHB. Bepirovirsen is designed to recognise and destroy the genetic components (i.e. RNA) of the hepatitis B virus that can lead to chronic disease, potentially allowing a person’s immune system to regain control.

Bepiroversen是一种三重作用研究性反义寡核苷酸（ASO），目前正在B-Well III期临床试验计划中进行评估，用于治疗CHB。Bepiroversen被设计用于识别和破坏可导致慢性疾病的乙型肝炎病毒的遗传成分（即RNA），从而有可能使人的免疫系统恢复控制。

Bepirovirsen inhibits the replication of viral DNA in the body, suppresses the level of hepatitis B surface antigen (HBsAg) in the blood, and stimulates the immune system to increase the chances of a durable and sustained response..

Bepiroversen抑制病毒DNA在体内的复制，抑制血液中乙型肝炎表面抗原（HBsAg）的水平，并刺激免疫系统增加持久和持续反应的机会。。

Bepirovirsen (previously known as ‘ISIS 505358 or IONIS-HBVRX’) was discovered by and jointly developed with Ionis Pharmaceuticals. Bepirovirsen is one of the ASO HBV programme assets in-licensed by GSK from Ionis Pharmaceuticals in August 2019.

Bepiroversen（以前称为“ISIS 505358或IONIS-HBVRX”）是由IONIS Pharmaceuticals发现并与之联合开发的。Bepiroversen是GSK于2019年8月从Ionis Pharmaceuticals获得许可的ASO HBV计划资产之一。

About GSK

GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

葛兰素史克是一家全球性生物制药公司，旨在将科学、技术和人才团结起来，共同战胜疾病。更多信息请访问gsk.com。